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AVANUTRI EQUIPMENT ZHONGSHAN CO

⚠️ Moderate Risk

FEI: 3034246969 • Zhongshan, Guangdong • CHINA

FEI

FEI Number

3034246969

📍

Location

Zhongshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Minan S Rd, No 228 Xiaojia Lane, Zhongshan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
2
Unique Violations
1/31/2025
Latest Refusal
1/31/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
80.8×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/31/2025
89IRPMASSAGER, POWERED INFLATABLE TUBE
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is AVANUTRI EQUIPMENT ZHONGSHAN CO's FDA import refusal history?

AVANUTRI EQUIPMENT ZHONGSHAN CO (FEI: 3034246969) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2025 to 1/31/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. AVANUTRI EQUIPMENT ZHONGSHAN CO's FEI number is 3034246969.

What types of violations has AVANUTRI EQUIPMENT ZHONGSHAN CO received?

AVANUTRI EQUIPMENT ZHONGSHAN CO has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about AVANUTRI EQUIPMENT ZHONGSHAN CO come from?

All FDA import refusal data for AVANUTRI EQUIPMENT ZHONGSHAN CO is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.